Papulopustular Rosacea Clinical Trial
Official title:
A Multi-Center, Open-Label, Long-Term Safety Study of S5G4T-1 to Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients
Verified date | December 2021 |
Source | Sol-Gel Technologies, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study SGT-54-02 (NCT03564119).
Status | Terminated |
Enrollment | 547 |
Est. completion date | November 13, 2019 |
Est. primary completion date | November 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for the extension study. 2. Participants must complete 12 weeks or within the Week 12 window time (± 4 days) of the double-blind treatment period of Study SGT-54-01 or Study SGT-54-02 and missed not more than 1 visit of Visits 3, 4 or 5 in Study SGT-54-01 or Study SGT-54-02. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | Sol-Gel | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Sol-Gel Technologies, Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. An SAE was defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event. A summary of all SAEs and Other AEs (non-serious) regardless of causality is located in 'Reported Adverse Events' Section. | Baseline up to Week 52 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03276936 -
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT02601963 -
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT02268474 -
Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea
|
N/A | |
Completed |
NCT01555463 -
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
|
Phase 3 | |
Active, not recruiting |
NCT03667222 -
Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT05150587 -
Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT03263273 -
Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT05343455 -
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
|
Phase 3 | |
Completed |
NCT01784133 -
A Twelve Week Safety and Efficacy Study in Rosacea
|
Phase 2 | |
Completed |
NCT01872715 -
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
|
Phase 4 | |
Completed |
NCT05296629 -
A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
|
Phase 3 | |
Completed |
NCT05838170 -
Study of TP-04 in Participants With Papulopustular Rosacea
|
Phase 2 | |
Recruiting |
NCT06013371 -
PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea
|
Phase 2 | |
Recruiting |
NCT03864978 -
Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test
|
Phase 2 | |
Completed |
NCT03564119 -
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
|
Phase 3 | |
Completed |
NCT03079531 -
Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea
|
Phase 1/Phase 2 | |
Completed |
NCT01045551 -
Open Label Pilot Study of Apremilast in Treatment of Rosacea
|
Phase 2 | |
Completed |
NCT03448939 -
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT05675501 -
Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
|
Phase 1 | |
Withdrawn |
NCT03883945 -
A Safety and Efficacy Study to Evaluate Rosacea
|
Phase 1/Phase 2 |